Beyondspring, Inc. · NASDAQ:BYSI
Beyondspring — Investor Presentation (October 2022)
27 slides from Beyondspring's investor presentation, October 2022
Slide 1: October 2022 | NASDAQ: BYSI
October 2022 | NASDAQ: BYSI
Slide 2: Disclaimer
Disclaimer This presentation has been prepared for informational purposes only. No money or other consideration is being solicited, and if sent in response, will not be accepted. This presentation shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor shal
Slide 3: Company Highlights
Company Highlights Positive Ph3 Data Positive Phase 3 data in 2 indications with Lead Asset - Plinabulin in 2 Indications Global Regulatory China NDA review ongoing in CIN; preparing to file NDA in NSCLC Strategy Deep Compelling pipeline of additional indications Pipeline Intellectual Strong IP and
Slide 4: Plinabulin Franchise
Plinabulin Franchise Clinical Confirmation Expand Transform Promising early clinical efficacy data Positive topline Phase 3 OS data Confirmed in 6 clinical studies & NDA Review in China CIN NSCLC Multiple Cancers (I/O Combo) 4
Slide 5: Mechanism with Broad Applications
Mechanism with Broad Applications Plinabulin Induces Dendritic Cell Maturation (the most potent APC), a Key Step in Initiating Anti-Cancer Durable Response ❷ Plinabulin ❸ Checkpoint Inhibitors Hit the Gas Release The Brakes Stimulates maturation of dendritic Optimize T cell response cells to increas
Slide 6: Pipeline
Pipeline Indication/Target Program Preclinical Phase 1 Phase 2 Phase 3 Trial Name / Collaborator NSCLC Plinabulin + Docetaxel DUBLIN-3 (2nd/3rd line) Late stage Plinabulin; PROTECTIVE-1 CIN Prevention Plinabulin + Pegfilgrastim & PROTECTIVE-2 SCLC Plinabulin + PD-1 + CTLA-4 (2nd/3rd line) Investigat
Slide 7: Chemotherapy-Induced Neutropenia (CIN) Prevention Indication
Chemotherapy-Induced Neutropenia (CIN) Prevention Indication 7
Slide 8: CIN Is an Unmet Medical Need in Week 1 After Chemotherapy
CIN Is an Unmet Medical Need in Week 1 After Chemotherapy Despite widespread G-CSF use, CIN is #1 reason for FN, ER visits, hospitalization, sepsis, mortality, and chemotherapy dose reduction and disruption1 Short-term Long-term G-CSF is more effective in week 2 after chemo Chemotherapy’s anti-cance
Slide 9: Met Primary Endpoint in PROTECTIVE-2 Phase 3 Study
Met Primary Endpoint in PROTECTIVE-2 Phase 3 Study Design: Double blind, global study (19 centers); 4 cycles Plinabulin 40 mg + Pegfilgrastim 6 mg N=111 Breast Cancer, R TAC Therapy 1:1 Placebo + Pegfilgrastim 6 mg N=110 Results: Proportion of Patients with NO Grade 4 Neutropenia (or DSN= 0 Days) in
Slide 10: Superior Improvement in Clinically Meaningful Endpoints Compared to Pegfilgrastim Alone
The Combination with Superior Improvement in Clinically Meaningful Endpoints Compared to Pegfilgrastim Alone Reduction of Incidence and Reduction of Profound Improvement of Severity of FN and Neutropenia (PN) Related Quality of Life Hospitalization Benefits Clinical Endpoints Profound Neutropenia En
Slide 11: 2nd/3rd Line NSCLC Indication
2nd/3rd Line NSCLC Indication 11
Slide 12: Severe Unmet Medical Needs – 2nd/3rd Line NSCLC, EGFR Wild Type
Anti- Cancer Severe Unmet Medical Needs – 2nd/3rd Line NSCLC, EGFR Wild Type • Large patient population with limited treatment options o EGFR wild type: ~85% western NSCLC and ~70% of Asian NSCLC patients o With immunotherapies moved to first line, Docetaxel-based therapies are the mainstay therapy
Slide 13: Met Primary Endpoint of OS in DUBLIN-3 Phase 3 Trial
Met Primary Endpoint of OS in DUBLIN-3 Phase 3 Trial Design: Single-Blinded (blinding for patients only), global study, around 60 sites Docetaxel + Plinabulin (DP) 2nd/3rd line R NSCLC, EGFR Wild Type 1:1 Docetaxel + Placebo (D) 50% 43.48% 45% 40.47% Results: 40% 35% • Significantly increased 31.11%
Slide 14: Met Primary Objective in Overall Survival (OS)
Anti- Cancer Met Primary Objective in Overall Survival (OS) HR = 0.82 14
Slide 15: Significant Reduction in Grade 4 Neutropenia
Significant Reduction in Grade 4 Neutropenia Cycle 1 Day 8 and All Cycles Day 8 Grade 4 neutropenia, Cycle 1 Day 8 Grade 4 neutropenia, All Cycles Day 8 50% 50% P<0.0001 P<0.0001 40% 40% Percentage of Patients Percentage of Patients 33.58% 30% 27.80% 30% 20% 20% 10% 10% 5.26% 5.13% 0% 0% Docetaxel +
Slide 16: Significant Improvement in Quality of Life Benefit
Anti- Significant Improvement in Quality of Life Benefit Cancer Q-TWiST (Quality-Adjusted Time Without Symptoms of Disease and Toxicity) Plinabulin + Docetaxel Docetaxel alone Clinically Meaningful Improvement of >18% in Q-TWiST. 16
Slide 17: Significant OS Benefit in Non-squamous NSCLC (2nd/3rd Line)
Anti- Significant OS Benefit in Non-squamous NSCLC (2nd/3rd Line) Cancer Plinabulin + Docetaxel vs. Docetaxel Nivolumab (PD-1) vs. Docetaxel 1 100 Docetaxel Docetaxel + Plinabulin Censored Log rank 80 Log rank p value = 0.002 p value = 0.0227 OS Probability (%) 60 HR = 0.73 HR = 0.75 40 20 0 Log-Ran
Slide 18: Potential Benefit of Plinabulin + Docetaxel in NSCLC (2nd/3rd line)
Anti- Potential Benefit of Plinabulin + Docetaxel in NSCLC (2nd/3rd line) Cancer With PD-1/PD-L1 moving to 1st line NSCLC, plinabulin + docetaxel could be the potential choice, with benefits vs. Docetaxel. • Significant survival benefit, with more pronounced survival benefit in non-squamous NSCLC po
Slide 19: Immuno-Oncology Combinations
Immuno-Oncology Combinations 19
Slide 20: Plinabulin as Potential Cornerstone Add-on Therapy to Current I/O Regimens
Plinabulin as Potential Cornerstone Add-on Therapy to Current I/O Regimens to Address Severe Unmet Medical Needs PD-1/PD-L1 Inhibitors Potential to greatly expand the - $30B global annual sales addressable market Current Severe Unmet Medical Needs Plinabulin Clinical Development 2/3rd Line: PD-1/PD-
Slide 21: Promising Efficacy (Phase I) Plinabulin + PD-1 + CTLA-4 Inhibitors in 2nd/3rd line SCLC
I/O Promising Efficacy (Phase I) Plinabulin + PD-1 + CTLA-4 Inhibitors in 2nd/3rd line SCLC Efficacy Analysis (ASCO 2021 Presentation) Waterfall plot of best overall response in target lesions compared to baseline PD-1/PD-L1 PD-1/PD-L1 Efficacy resistant therapy naïve Analysis (n=7) (n= 6) Number of
Slide 22: Regulatory Pathway & Commercial Plan
Regulatory Pathway & Commercial Plan 22
Slide 23: Regulatory Pathway
Regulatory Pathway Near-Term CIN: Ongoing NDA package review in areas such as Clinical, Clinical Pharmacology, Preclinical Pharmacology, Toxicology, Biostatistics, and Compliance by CDE at NMPA in China; Seek regulatory clarity in the US. NSCLC: Ongoing preparation to file for NDA package in China e
Slide 24: Commercial Partner Hengrui for Plinabulin in Greater China
Commercial Partner Hengrui for Plinabulin in Greater China Exceptional synergy between plinabulin and Hengrui pipeline ➢ Hengrui is the leader in oncology product R&D and commercialization in China • Established in 1970; Listed on Shanghai Stock Exchange in 2000 (Shanghai stock exchange ticker: 6002
Slide 25: Commercial Potential in CIN Prevention Market in China
Commercial Potential in CIN Prevention Market in China G-CSF product sales in China Overview of marketed long-acting G-CSF products in China2 (¥100,000,000 RMB) Cost per cycle Medical Cost per cycle Product Company Availability (price paid by Insurance (Original) 803 insurance) (year) +40% Filgrasti
Slide 26: Summary
Summary Positive Ph3 Data Positive Phase 3 data in 2 indications with Lead Asset - Plinabulin in 2 Indications Global Regulatory China NDA review ongoing in CIN; preparing to file NDA in NSCLC Strategy Deep Compelling pipeline of additional indications Pipeline Intellectual Strong IP and technology
Slide 27: www.beyondspringpharma.com
www.beyondspringpharma.com 27